[乌蔹莓注射液半成品指纹图谱研究]
[Study on fingerprint of unfinished product of Nauclea injection].
作者信息
Li Tao, Wang Wei-Jian, Hu Xin
机构信息
Beijing Hospital, Beijing 100730, China.
出版信息
Zhongguo Zhong Yao Za Zhi. 2005 Aug;30(15):1156-8.
OBJECTIVE
To establish HPLC fingerprints of unfinished product of Nauclea injection.
METHOD
A high performance liquid chromatography assay was developed with an Agilent-Extend C18 column, a gradient elution:water-5% acetonitrile (10 min), 5% acetonitrile-10% acetonitrile (10-60 min), 50% acetonitrile-water (60-70 min), a 0.7 mL x min(-1) flow rate, at detection wavelength, 245 nm within a 70 min total elution time.
RESULT
The RSD of relative retention time and peak area of coexist peaks meet to method requirement during the investigation of precision, stability and repeatibity trials. All of the 10 batches of samples share a high similarity.
CONCLUSION
This method can be used to control the quality of unfinished product of Nauclea injection.
目的
建立乌蔹莓注射液半成品的高效液相色谱指纹图谱。
方法
采用高效液相色谱法，以Agilent-Extend C18柱为色谱柱，梯度洗脱：水-5%乙腈（10分钟），5%乙腈-10%乙腈（10-60分钟），50%乙腈-水（60-70分钟），流速0.7 mL·min⁻¹，检测波长245 nm，总洗脱时间70分钟。
结果
在精密度、稳定性和重复性试验考察中，共存峰相对保留时间和峰面积的相对标准偏差符合方法要求。10批样品相似度较高。
结论
该方法可用于控制乌蔹莓注射液半成品的质量。
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